Application Nr Approved Date Route Status External Links
NDA204442 None Subcutaneous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1. Indications And Usage Probuphine Is Indicated For The Maintenance Treatment Of Opioid Dependence In Patients Who Have Achieved And Sustained Prolonged Clinical Stability On Low-To-Moderate Doses Of A Transmucosal Buprenorphine-Containing Product (I.e., Doses Of No More Than 8 Mg Per Day Of Subutex Or Suboxone Sublingual Tablet Or Generic Equivalent). Probuphine Should Be Used As Part Of A Complete Treatment Program To Include Counseling And Psychosocial Support. Probuphine Is Not Appropriate For New Entrants To Treatment And Patients Who Have Not Achieved And Sustained Prolonged Clinical Stability, While Being Maintained On Buprenorphine 8 Mg Per Day Or Less Of A Subutex Or Suboxone Sublingual Tablet Equivalent Or Generic Equivalent. Probuphine Contains Buprenorphine, A Partial Opioid Agonist. Probuphine Is Indicated For The Maintenance Treatment Of Opioid Dependence In Patients Who Have Achieved And Sustained Prolonged Clinical Stability On Low-To-Moderate Doses Of A Transmucosal Buprenorphine- Containing Product (I.e., Doses Of No More Than 8 Mg Per Day Of Subutex Or Suboxone Sublingual Tablet Or Generic Equivalent). Probuphine Should Be Used As Part Of A Complete Treatment Program To Include Counseling And Psychosocial Support. Probuphine Is Not Appropriate For New Entrants To Treatment And Patients Who Have Not Achieved And Sustained Prolonged Clinical Stability, While Being Maintained On Buprenorphine 8 Mg Per Day Or Less Of A Subutex Or Suboxone Sublingual Tablet Or Generic Equivalent.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Buprenorphine Hydrochloride BUPRENORPHINE HYDROCHLORIDE ZINC100373348

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